01 2Helsinn Advanced Synthesis
01 1ANAMORELIN HYDROCHLORIDE (API)
02 1ANAMORELIN HYDROCHLORIDE, 100 MG TABLETS
01 2Switzerland
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31120
Submission : 2016-11-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30961
Submission : 2016-11-16
Status : Active
Type : II
A Anamorelin hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Anamorelin hydrochloride, including repackagers and relabelers. The FDA regulates Anamorelin hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Anamorelin hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Anamorelin hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Anamorelin hydrochloride supplier is an individual or a company that provides Anamorelin hydrochloride active pharmaceutical ingredient (API) or Anamorelin hydrochloride finished formulations upon request. The Anamorelin hydrochloride suppliers may include Anamorelin hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Anamorelin hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Anamorelin hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Anamorelin hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Anamorelin hydrochloride DMFs exist exist since differing nations have different regulations, such as Anamorelin hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Anamorelin hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Anamorelin hydrochloride USDMF includes data on Anamorelin hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Anamorelin hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Anamorelin hydrochloride suppliers with USDMF on PharmaCompass.
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